Walgreens Collaborates with Cardiovascular Research Foundation on Valvular Heart Disease Clinical Trial

Walgreens and the Cardiovascular Research Foundation (CRF) announced a collaboration on a population-based clinical trial that seeks to quantify the prevalence of valvular heart disease (VHD) in older Americans. Under the terms of the deal, Walgreens will leverage its broad national presence to help recruit potential trial participants employing its clinical trials services with an eye toward enrolling a population that is representative of the diversity of the U.S. population as a whole.

The PREVUE-VALVE study also aims to recruit older participants who are often excluded from clinical trials in the hopes that data from the trial can aid in the development of new therapies and diagnostics for VHD.

“The aging population has led to a surge in the incidence and prevalence of valvular heart disease in the United States,” notes David J. Cohen, MD, director of Clinical and Outcomes Research at CRF. “Unfortunately, many patients with valvular heart disease remain untreated or receive treatment later than recommended due to various barriers. At the Cardiovascular Research Foundation, we believe efficient clinical trials are essential for arming us with insights to effectively tackle this critical health challenge.”

Finding older patients and ensuring a representative population for the study will be aided by the nearly 9,000 retail locations operated by Walgreens in the U.S. that serve approximately 160 million customers. The company has noted previously that 78% of the U.S. population lives within five miles of a Walgreens location and roughly half its stores are located in socially vulnerable areas. The recruitment effort will employ a variety of proprietary tools to reach recruitment targets including social longitudinal pharmacy data and social determinants of health. To aid in recruitment and retention of consented participants, all study procedures will be conducted in participant homes, eliminating the potential barrier of needing to travel to a central clinical trial site.

The broad reach of Walgreens should help fill in gaps of previous research into VHD, which has primarily been conducted in largely homogenous populations with minimal diversity, particularly in respect to race and ethnicity. In addition, the focus on recruiting older patients who are known to have a higher incidence of VHD, seeks to resolve the bias of other clinical studies that have excluded them from their trials. According to a press release announcing this recruitment collaboration, the PREVUE-VALVE study will provide relevant testing and treatment insights for the populations most affected by the disease.

“We know that older adults are vastly underrepresented in clinical trials and research despite being disproportionately impacted by many diseases,” notes Ramita Tandon, chief clinical trials officer at Walgreens. “Walgreens is proud to leverage our expertise and capabilities in inclusive clinical trial recruitment in partnership with the Cardiovascular Research Foundation and other high-caliber collaborators to improve cardiovascular research for a population with significant unmet needs.”

According to a company press release, in a similar cardiovascular Phase III study, Walgreens successfully exceeded its recruitment target “within weeks.” By using real-world data, the company was able to recruit traditionally underrepresented populations reaching participation rates from Black/African Americans and Hispanic/Latino populations of 17% and 19%, respectively. These rates are significantly higher than 2020 nationwide averages that saw 8% participation of Black/African Americans and 11% of the Hispanics/Latinos.

“Partnering with Walgreens will help us engage a broader and more representative patient population for enrollment in the PREVUE-VALVE study so that we can improve our ability to diagnose valvular heart disease before the onset of irreversible cardiac damage, which will allow for more timely treatment and ultimately, better health outcomes, for our patients,” notes Cohen of the CRF.